BEUDAMED
    FDA Enforcement Class II Terminated

    Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.

    Recall: Z-0608-2016 · Reported January 13, 2016

    Enforcement

    Recall Number
    Z-0608-2016
    Event ID
    72960
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Otto Bock Healthcare GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    January 13, 2016
    Initiation Date
    January 4, 2016
    Classification Date
    January 7, 2016
    Termination Date
    May 2, 2016
    Address
    Max-Nader-Str. #15, N/A, Duderstadt, N/A, N/A, Germany

    Description

    Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.

    Reason

    Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced between 27 April 2015 and 17 November 2015 due to a service error where the wrong Loctite was used during repair.

    Code Info

    All serviced between 27 April 2015 and 17 November 2015

    Distribution

    Nationwide Distribution.

    Quantity

    40 units